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Trial registered on ANZCTR


Registration number
ACTRN12612000510842
Ethics application status
Approved
Date submitted
10/05/2012
Date registered
14/05/2012
Date last updated
14/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing Language Impairment and Recovery of Aphasia after stroke in Singaporeans who speak English and/or Mandarin
Scientific title
Assessing Language Impairment and Recovery of Aphasia after stroke using The Singapore Aphasia Test in Singaporeans who speak English and/or Mandarin
Secondary ID [1] 280472 0
nil
Universal Trial Number (UTN)
U1111-1130-6328
Trial acronym
SGAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 286446 0
Aphasia 286459 0
Condition category
Condition code
Stroke 286708 286708 0 0
Ischaemic
Stroke 286709 286709 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 286713 286713 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Singapore Aphasia test (SGAT) is a locally developed diagnostic assessment of language function. It has an English and a Mandarin verson. The English SGAT comprises 45 subtests while the Mandarin SGAT comprises 47 subtests. The number of subtests is higher in the Mandarin SGAT as it includes two further subtests namly the Tone perception and Tone production subtests. Together, the subtests evaluate language performance across the following areas: spontaneous speech, recall/memory, perception skills, auditory comprehension, verbal expression, reading comprehension and written expression.

Participant responses will be administered one-on-one by speech-language therapists who are proficient in English and Mandarin. Test performance will be scored on-line and will be video-recorded for reliability analysis. In cases where the participant is bilingual in English and Mandarin, both language versions of the SGAT will be administered. For such cases, the two tests will be administered with an interval of two weeks between testing. Language testing is expected to last approximately 1-2hours. SGAT will be re-administered after 6 months .
Intervention code [1] 284834 0
Diagnosis / Prognosis
Intervention code [2] 284838 0
Early detection / Screening
Comparator / control treatment
Short form of Boston Diagnostic Aphasia Examination will be administered only for randomly selected English-speaking participants who underwent testing using the SGAT-English. This is an English test of aphasia which has been chosen to further validate the SGAT against an establised and normed aphasia test. BDAE will be administered one-on-one by speech-language therapists who are proficient in English. Testing is not exepected to exceed 2 hours each. BDAE will be adminstered at baseline and again after 6-months.
Control group
Active

Outcomes
Primary outcome [1] 287102 0
Performance scores on individual items and subtests in the Singapore Aphasia Test
Timepoint [1] 287102 0
Baseline and 6 months from commencement
Secondary outcome [1] 297378 0
Aphasia Severity Rating Scale
Timepoint [1] 297378 0
Baseline and 6 months from commencement
Secondary outcome [2] 297379 0
Boston Diagnostic Aphasia Examination - Short Form
Timepoint [2] 297379 0
Baseline and 6 months from commencement

Eligibility
Key inclusion criteria
Medically stable after a single, unilateral left hemisphere cerebrovascular accident (CVA), diagnosed clinically and confirmed by imaging study.

Less than 3 months post onset of CVA at time of recruitment.

Right-handed as determined by positive score on the Simplified hand preference questionnaire

At least primary school education

Language proficiency rating of at least 3 for speaking and understanding in English and/or Mandarin as determined by the Language Background Questionnaire.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hearing loss, alcohol or substance abuse as self-reported or determined from medical files.

Visual perceptual difficulties as determined by subtests 1-4 of the visual perception test

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 4300 0
Singapore
State/province [1] 4300 0

Funding & Sponsors
Funding source category [1] 285229 0
Government body
Name [1] 285229 0
Ministry of Health
Country [1] 285229 0
Singapore
Primary sponsor type
Individual
Name
Valerie Lim Puay Cheng
Address
Speech Therapy Department, Block 1 Level 1
Singapore General Hospital
Outram Road
Singapore 169608
Country
Singapore
Secondary sponsor category [1] 284097 0
Hospital
Name [1] 284097 0
Singapore General Hospital
Address [1] 284097 0
Outram Road
Singapore 169608
Country [1] 284097 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287239 0
Singhealth Centralisd Institute Review Board
Ethics committee address [1] 287239 0
Ethics committee country [1] 287239 0
Singapore
Date submitted for ethics approval [1] 287239 0
20/04/2012
Approval date [1] 287239 0
03/05/2012
Ethics approval number [1] 287239 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34165 0
Address 34165 0
Country 34165 0
Phone 34165 0
Fax 34165 0
Email 34165 0
Contact person for public queries
Name 17412 0
Jason Ling
Address 17412 0
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3, #06-08
Singapore 150168
Country 17412 0
Singapore
Phone 17412 0
+6563266377
Fax 17412 0
Email 17412 0
jason.ling.w.j@sgh.com.sg
Contact person for scientific queries
Name 8340 0
Valerie Lim Puay Cheng
Address 8340 0
Singapore General Hospital
Speech Therapy Department
Outram Road
Singapore 169608
Country 8340 0
Singapore
Phone 8340 0
+6563265481
Fax 8340 0
Email 8340 0
valerie.lim.p.c@sgh.com.sg

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.